GxP-Validated RAG Knowledge Assistant
A retrieval-augmented assistant for your SOPs, batch records, deviations, regulatory submissions — and the V-model validation file that lets you put it in production under GxP. Six to eight weeks. Working pipeline + the audit evidence package + the validation strategy.
A4BEE Service
GxP-Validated RAG Knowledge Assistant
Duration
6–8 weeks depending on corpus complexity
Who it's for
Pharma + biotech orgs with 10k+ regulated documents (SOPs, batch records, deviations, CAPAs, submissions) and the operational appetite to use them via an AI assistant
Format
Remote — kickoff workshop on-site week 1 if requested; weekly progress reviews; demo to sponsor + QA at end of week 6
Engagement size
1 Senior Engineer + 1 Validation Lead + 0.5 Solution Architect
Document types supported
SOPs · batch records · deviations + CAPAs · change controls · regulatory submissions (CTD modules) · supplier qualifications · validation protocols
What's GxP about it
Full V-model artefacts (URS → FS → CS → DS → IQ → OQ → PQ), traceability matrix, 21 CFR Part 11-compatible audit logging
Stack approach
Open-source vector store (Qdrant or Weaviate) + LlamaIndex / LangChain + Claude — no vendor lock at any layer
Out of scope by design
Model fine-tuning · multi-language corpora in same retrieval index · real-time write-back into source systems (read-only RAG only)
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What you'll get, how we run it, the FAQ, and the book-now CTA are available to signed-in users. Free to register — and you get your assessment history in the same account.